B-FREE in the UP! Improving Recovery After a Knee Replacement With Blood-Flow Restriction Exercise Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Muscle size
研究概览
简要总结
This study will determine the safety and efficacy of using blood-flow restriction exercise enhancement (B-FREE) to overcome persistent quadriceps muscle weakness that occurs following a total knee replacement (TKR).
详细描述
This study aims to determine the safety and efficacy of using B-FREE to overcome persistent quadriceps muscle weakness that occurs following a TKR. We hypothesize that B-FREE can provide a safe training stimulus and offer a home-based program to restore quadriceps muscle strength and improve functional mobility. Specifically, subjects that have a TKR will perform B-FREE at home (light weights with resistance bands and walking) 3x/wk for 10 weeks. Quadriceps muscle strength, balance, and functional mobility will be assessed before and after the program. Changes in these variables will be compared to healthy age-matched uninjured controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40-75 years of age
- •Have had a unilateral TKA > 6 months prior to participation (Arm 1)
- •No previous history of knee injury/surgery (Arm 2)
排除标准
- •Are a smoker
- •Have diabetes
- •Have suffered a heart attack or stroke
- •Have any cardiopulmonary disorders (hypertension discussed below)
- •Have been diagnosed with any neurological disorders
- •Have any implanted devices such as but not limited to a pacemaker or pain pump
- •Uncontrolled (not medicated) Stage 1 hypertension or Stage 2 hypertension
研究组 & 干预措施
Adults with TKR Perform Home Exercise Program
Participants that have a total knee replacement will complete a home-based exercise program
干预措施: B-FREE (Other)
Healthy Controls Only
Participants that have no history of knee joint dysfunction will serve as age-matched uninjured controls
结局指标
主要结局
Change in Muscle size
时间窗: Change from baseline at 10 weeks
quadriceps muscle thickness
Change in Muscle strength
时间窗: Change from baseline at 10 weeks
quadriceps muscle strength
次要结局
- Change in Balance(Change from baseline at 10 weeks)
- Change in Walking performance(Change from baseline at 10 weeks)